Implementing food safety law to pose big challenges

Dec 23, 2010 (CIDRAP News)  The big food safety bill passed this week hands a heavy bundle of new responsibilities to the Food and Drug Administration (FDA), and most of the changes specified in the legislation are unlikely to come swiftly or easily.

The FDA is expected to face difficult budget constraints in the current cost-cutting political climate, and the new law itself sets fairly lengthy timelines for implementing key requirements. For example, though the law calls for more frequent inspections of food facilities, it gives the FDA 5 years to complete its first round of inspections of "high-risk" facilities.

The Food Safety Modernization Act passed the House 2 days ago and is awaiting President Obama's signature. Besides calling for more inspections, it requires domestic food facilities to develop contamination-prevention plans, increases monitoring of imported foods, expands FDA access to food records, and calls for improvements in foodborne-disease surveillance and tracing of contaminated foods, among many other things.

FDA spokesman Douglas Karas said today it would be "premature" for the agency to discuss implementation of the bill. "When the bill becomes law it will require a great deal of evaluation and planning to implement the provisions. It would be counterproductive for the FDA to engage in speculation," he told CIDRAP News.

Cost estimated at $1.4 billionIn August the Congressional Budget Office estimated the net increase in costs associated with the bill at $1.39 billion over the next 5 years (2011 through 2015). (The estimate was based on the Senate bill, S 510, which is what finally emerged from Congress, with only minor changes.) The estimate assumes the FDA will collect some money in new fees authorized by the law in connection with food recalls and import inspections.

When the 112th Congress convenes in January, Republicans will take control of the House, and with worries about the federal deficit peaking, it's highly uncertain how much money the FDA will get to carry out its new responsibilities.

"What the FDA will be able to do is going to depend on funding, but the idea is certainly that the FDA will have to hire more people to implement this bill," said Chris Waldrop of the Consumer Federation of America (CFA), one of many groups that supported the bill.

"I think it's going to be hard," Waldrop said. "The Republicans are talking about decreasing the budget across the board, and we're going to have to make the case that the FDA needs additional funding."

Indeed, an Iowa congressman who sits on a subcommittee that controls FDA funding predicted there will be little if any new money to help the agency implement the law, according to a report yesterday in the Des Moines Register. "We simply don't have the money to pay for it," Rep. Tom Latham, a Republican who voted against the bill, told the newspaper.

Republicans in the House voted heavily against the bill, but Latham denied that Republics would withhold funds just to block its implementation. "The problem is we don't have funding to start with," he said.

Various numbers have been mentioned concerning how many new staff the FDA will need to meet its new responsibilities. The Register story put the figure at 2,000.

The law calls for the FDA to increase its relevant field staff to 4,000 in 2011 and to 5,000 by 2014, a copy provided by the CFA shows. Information from an FDA spokesman put the total staff for the three FDA centers involved at about 5,000 in 2009, but it was not clear how many of those were field personnel.

The new law also calls for the addition of 150 employees for food defense, which includes dealing with deliberate contamination and smuggling, in 2011.

Long lead timesEven if funds become available, the timelines in the law indicate that key requirements and programs will be implemented gradually.

"The FDA asked for and was given a very long lead time for implementation," Caroline Smith de Waal, food safety director for the Center for Science in the Public Interest, told the New York Times this week.

For example, the legislation says that in general the requirement for food facilities to analyze risks and develop prevention plans will take effect in 18 months. In fact, it gives the FDA 18 months to develop standards for food facilities to use in developing their plans.

While the law calls for more inspections of food facilities, that doesn't mean inspections will be frequent in the ordinary sense of the word. As mentioned, the measure gives the FDA 5 years to inspect domestic facilities that produce high-risk foods. After that, they are to be inspected at least every 3 years.

Under the law, the FDA is supposed to inspect other domestic food facilities within 7 years from the date of enactment, and then at least every 5 years. The agency is authorized to rely on other federal agencies or state or local agencies to conduct the inspections.

In that vein, the law also calls on the FDA to develop strategies to improve the food safety and defense capabilities of state and local agencies, including outbreak-response capabilities, according to a Congressional Research Service summary of the bill. The agency is supposed to complete a review of state and local capacities and needs within a year.

In other provisions, the legislation gives the FDA 9 months to launch pilot projects to test new systems to trace contaminated foods and 18 months to report on the results of those projects.

Concerning imported foods, the FDA is required to develop guidance within a year to help food importers develop programs to verify the safety standards of foreign suppliers. Also, the FDA has 18 months to launch a program to permit faster review for foods imported by businesses that participate in a voluntary qualified importer program.

The legislation calls on the FDA to prepare numerous special reports. For just one example, the agency is required to conduct a study and report within 18 months on the distribution of food facilities by type and size of operation and on the foodborne-illness risk associated with each size and type.

The FDA has a head start on at least one project required by the new law: the development of safety regulations for produce. The agency has been working on such standards in recent months.

"To some extent I think they were waiting for the bill to be finalized so they could be sure whatever they put out would meet the requirements of the law," said Waldrop.